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Completed

NCT Number: NCT02170701

BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery

* To determine the therapeutic window of BIBR 1048 in order to select doses for further studies in the development plan. * Twice daily regimen will be tested for most dose levels and once daily administration will also be evaluated when appropriate.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled to undergo a primary elective total hip replacement
  • Male of female being 18 years or older
  • Patients weighing at least 40 kg
  • Written informed consent for study participation

Exclusion criteria

  • Bleeding diathesis, constitutional or acquired coagulation disorders
  • Major surgery or trauma (e.g. hip fracture) within the last three months. Patients with previous hip fractures associated with plate revisions at any time will be excluded
  • Cardiovascular disease including uncontrolled hypertension at time of enrolment or history of myocardial infarction within the last 6 months
  • Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks
  • Known history of deep venous thrombosis (DVT)
  • Gastrointestinal or pulmonary bleeding within the last year
  • Known liver disease Aspartate transaminase (AST) or Alanine transaminase (ALT) > 3 x ULN)
  • Known renal disease (serum creatinine > 1.5 x ULN)
  • Use of long- term anticoagulants, antiplatelet drugs, or fibrinolytics within 7 days prior to hip replacement operation (also contraindicated during the period of prophylaxis)
  • Women of childbearing potential
  • Known allergy to radiopaque contrast media
  • Known thrombocytopenia (prior platelet count below 100,000 cells/microliter)
  • Active malignant disease
  • Current H2 blocker or proton pump inhibitor treatment
  • Current cytostatic treatment
  • Treatment with an investigational drug in the past month
  • Leg amputee
  • Known alcohol or drug abuse

Treatment and study plan

BIBR 1048

Drug

Ascending doses (in mg) given twice daily

Primary outcomes

  1. Rate of venous thrombolic events

    Time frame: Up to day 10 after hip surgery

  2. Changes from baseline in activated partial thromboplastin time (aPTT)

    Time frame: From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10)

  3. Changes from baseline in ecarin clotting time (ECT)

    Time frame: From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10)

  4. Changes from baseline in thrombin time (TT)

    Time frame: From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10)

  5. Rate of major bleeding events during treatment phase

    Time frame: Start of treatment (day 0) until end of treatment (up to day 10)

  6. Cpre,ss (predose plasma concentrations at steady state)

    Time frame: baseline and predose from day 1 to last treatment day

  7. Cmax,ss (maximum plasma concentration at steady state (day 4))

    Time frame: Day 4

  8. Tmax,ss (time to reach Cmax,ss)

    Time frame: baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment

  9. CLtot/f (total clearance of drug from plasma after oral administration)

    Time frame: baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment

  10. AUCss (area under the plasma concentration curve of one dosing interval at steady state)

    Time frame: baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment

  11. PTF (percent peak trough fluctuation for the last dosing interval)

    Time frame: baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment

  12. Cmax,ss (maximum plasma concentration at steady state (day 4))

    Time frame: Day 4 before and 0.5, 1, 2, 4 , 8, 12 , 14 h after treatment

Secondary outcomes

  1. Venous thromboembolism diagnosed during the follow-up period

    Time frame: Up to 6 weeks after surgery (day 42)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Multicenter, Open-label, Ascending Dose Study of BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery. Bistro I

Important dates

Study start
2000
Primary completion
2001
First posted
Jun 23, 2014
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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